Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly
FIT
2 other identifiers
interventional
108
1 country
2
Brief Summary
The aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Findings from study laboratories have suggested that a regional specific training stimulus (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel combination of resistance training and aerobic training applied simultaneously, and in a serial manner, to specific regions of the body. It involves high-intensity and frequency muscle contractions, generating a targeted exercise stimulus, without producing excessive cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at multiple, strategically selected peripheral sites, in a serial manner will elicit local vascular and muscular changes, thereby preparing individuals at elevated risk of losing independence, to respond and progress more favorably to whole-body exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedMarch 4, 2014
February 1, 2014
2.2 years
July 11, 2013
February 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change In Exercise Capacity
Exercise capacity was assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption and peak walking time.
Baseline, 4 weeks, and 12 weeks
Change in Maximal Strength
Skeletal muscle strength was assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
Baseline, 4 weeks, and 12 weeks
Secondary Outcomes (3)
Change in Functional Ability
Baseline, 4 weeks and 12 Weeks
Change In Vascular Function
Baseline, 4 weeks, and 12 weeks
Change in Skeletal Muscle Physiology
Baseline, 4 weeks, and 12 weeks
Study Arms (2)
Regional Specific Training (RSTS)
EXPERIMENTALThe RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
Aerobic Exercise (AE)
EXPERIMENTALWhole-body aerobic exercise at \>50% of heart rate reserve (HRR) for 45 minutes, three days per week.
Interventions
The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
Whole-body aerobic exercise at \>50% of heart rate reserve (HRR) for 45 minutes, three days per week.
Eligibility Criteria
You may qualify if:
- \>70 yrs of age
- Sedentary (exercising \<1 day/wk)
- Non-smokers
- Able to ambulate without use of an assistive device
- Able to walk between 200-450m on a 6-minute walk test
You may not qualify if:
- Oxygen dependent
- Recent medications changes (within 3 months)
- Current Smokers
- Fixed-rate pacemakers
- Uncontrolled hypertension or Type II diabetes
- Positive ECG changes or angina during CPX testing
- Unable to complete a maximal CPX to volitional fatigue
- AHA Class D, or NYHA Class III or IV heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (2)
Pennington Biomedical Center
Baton Rouge, Louisiana, 70808, United States
Duke Center for Living; Wallace Clinic
Durham, North Carolina, 27710, United States
Related Publications (1)
Woessner MN, Welsch MA, VanBruggen MD, Johannsen NM, Credeur DP, Pieper CF, Sloane R, Earnest CP, Ortiz De Zevallos Munoz J, Church TS, Ravussin E, Kraus WE, Allen JD. Impact of a Novel Training Approach on Hemodynamic and Vascular Profiles in Older Adults. J Aging Phys Act. 2022 Apr 1;30(2):196-203. doi: 10.1123/japa.2020-0509. Epub 2021 Aug 4.
PMID: 34348230DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason D Allen, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 15, 2013
Study Start
September 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
March 4, 2014
Record last verified: 2014-02